In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be administered before the first and second EPO/placebo administration. The 24-week treatment period will be followed by a 24-week observation period.

Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis

The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Patients with primary progressive MS or secondary progressive MS without relapses during the last 1 year will be suitable for the trial. In all 56 patients will be enrolled into the study.

The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.

Eligibility

Ages Eligible for Study:

19 Years to 60 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age between 19 and 60 years

primary progressive MS or secondary progressive MS without relapses during the last one year

duration of the disease of at least 2 years Clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. In addition, progression must be documented by an increase in the EDSS score of at least 0.5 points at any time during the 2 years prior to Screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).

EDSS (Expanded Disability Status Scale) 4.0-6.5

MRI fulfilling the Barkhof criteria for MS

written informed consent

Exclusion Criteria:

pregnancy or period of breastfeeding or missing adequate contraceptive protection

treatment with steroids in the last 30 days

treatment with interferons, glatiramer acetate or IVIG in the last1 month prior to enrolment

treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01144117